UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050860 |
|---|---|
| Receipt number | R000057613 |
| Scientific Title | Social implementation study of multi-component physical activity for the elderly living in the community at an exercise facility. |
| Date of disclosure of the study information | 2023/04/18 |
| Last modified on | 2024/04/17 12:53:43 |
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Basic information
Public title
Social implementation study of multi-component physical activity for the elderly living in the community at an exercise facility.
Acronym
Social implementation study of physical activity for the elderly at an exercise facility.
Scientific Title
Social implementation study of multi-component physical activity for the elderly living in the community at an exercise facility.
Scientific Title:Acronym
Social implementation study of physical activity for the elderly at an exercise facility.
Region
| Japan |
Condition
Condition
Physical inactive
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of multi-component exercise in an exercise facility on physical function, improved exercise habits, and well-being, using implementation research methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical function (Timed up and go test) and implementation outcomes before the intervention and after 3 and 9 months
Key secondary outcomes
Quantity of physical activity and exercise habits, well-being before the intervention and after 3 and 9 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Multicomponent (multi-component) exercise is performed at least once a week at an exercise facility. The duration of the intervention will be 9 months.
Interventions/Control_2
Waiting control group: conduct life as usual for the first three months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Have undergone a medical check-up at the time of participation in the study.
Be able to participate in a regular exercise program at an exercise facility at least once a week.
Do not have an exercise habit (exercise at least twice a week for at least 30 minutes per session for at least one year).
Key exclusion criteria
Do not have permission from their family doctor to exercise and have exercise restrictions.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
223-8521
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-566-1090
yoguma@keio.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
223-8521
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-566-1090
Homepage URL
yoguma@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Enoshima island spa
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Enoshima island spa
Name of secondary funder(s)
Keio University
IRB Contact (For public release)
Organization
Research Ethics Review Committee, Research Centre for Sports Medicine, Keio University
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
Tel
045-566-1090
yoguma@keio.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
41 recruits were completed in 2023, and the study is continuing in 2024 to reach the target sample size.
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057613
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
